Endophthalmitis tied to repackaged bevacizumab

September 7, 2011

Use of repackaged intravitreal injections of bevacizumab (Avastin, Genentech) has caused a cluster of serious eye infections in the Miami area, according to the FDA.

Silver Spring, MD-Use of repackaged intravitreal injections of bevacizumab (Avastin, Genentech) has caused a cluster of serious eye infections in the Miami area, according to the FDA.

The Florida Department of Health notified the federal agency of a cluster of streptococcal endophthalmitis infections in three clinics following intravitreal injection of repackaged bevacizumab. Investigators traced the tainted injections to a pharmacy in Hollywood, FL, that had repackaged the bevacizumab from sterile, injectable, 100 mg/4 ml, single-use, preservative-free vials into individual 1-ml single-use syringes and then distributed the bevacizumab to several eye clinics.

The FDA is aware of eye infections in at least 12 patients in at least three clinics. Although all of these patients had visual deficits before receiving the bevacizumab injections, some of these patients subsequently lost all remaining vision in the affected eye because of endophthalmitis.

The FDA and Florida health officials continue to investigate the cause of the infection. Although the investigation is not yet complete, the common link for the infections is the pharmacy that repackaged the bevacizumab and the single lot of bevacizumab used in the repackaging.

Repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections, according to the FDA. The agency encourages health-care professionals to obtain drugs from appropriate, reliable sources and to administer them properly.

Any adverse events, side effects, or product quality problems related to the use of repackaged bevacizumab may be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting program by:

1. Completing and submitting a report online at www.fda.gov/MedWatch/report.htm or
2. Downloading a reporting form or calling 800/332-1088 to request a form, then completing and returning the form to the address on the pre-addressed form or submitting the form by fax to 800/FDA-0178.